Status:
RECRUITING
A Study of Navenibart in Participants With Hereditary Angioedema
Lead Sponsor:
Astria Therapeutics, Inc.
Conditions:
Hereditary Angioedema (HAE)
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
This is a Phase 3 multicenter, randomized, double-blind, placebo-controlled clinical trial evaluating the safety and efficacy of subcutaneous administration of navenibart in adult and adolescent parti...
Eligibility Criteria
Inclusion Criteria:
-
Documented diagnosis of HAE (Type 1 or 2). The following must be met:
- Documented clinical history consistent with HAE
- Lab findings consistent with HAE Type 1 or 2
-
Experienced at least 2 HAE attacks during the Run-In period, as confirmed by an investigator based on meeting the protocol-specified definition of an HAE attack.
Exclusion Criteria:
-
Any concomitant diagnosis of another form of chronic angioedema, such as acquired C1 inhibitor deficiency, HAE with normal C1-INH (also known as HAE type 3), idiopathic angioedema, or angioedema associated with urticaria.
-
Use of therapies prescribed for the prevention of HAE attacks may not be used during the trial or within the below time frames prior to the Run-In Period (adult participants may be on these medications at the time of the Screening Visit, but will need to washout prior to entering the Run-In Period).
- Tranexamic acid, oral danazol, oral stanazolol, and oral oxandrolone within 3 days prior to Run-In
- Plasma-derived C1INH for LTP within 14 days prior to Run-In
- Berotralstat within 21 days prior to Run-In
- Lanadelumab within 70 days prior to Run-In
- Garadacimab within 90 days prior to Run-In
Key Trial Info
Start Date :
March 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
145 Patients enrolled
Trial Details
Trial ID
NCT06842823
Start Date
March 20 2025
End Date
September 1 2027
Last Update
April 9 2026
Active Locations (85)
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1
Site 9
Birmingham, Alabama, United States, 35209
2
Site 2
Scottsdale, Arizona, United States, 85251
3
Site 3
Little Rock, Arkansas, United States, 72205
4
Site 26
San Diego, California, United States, 92122